Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan® (PRO-179/I)

Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®, on the Ocular Surface of Clinically Healthy Subjects.

Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.

Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.

Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects.

Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: PRO 179; Drug: Travatan 0.004 % Ophthalmic Solution

Detailed Description

Number of patients: n= 24, 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.

duration: 10 days.

Duration of subject in the study: 15 to 22 days.

Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.

The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).

Statistical methodology:

The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. The difference between the qualitative variables will be analyzed by means of X2 (Chi2) or Fisher's exact. An alpha ≤ 0.05 will be considered significant.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45160
      • Jose Navarro Partida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be clinically healthy.
• Have the ability to give their signed informed consent and show willingness to comply with the study procedures
• Have an age between 18 to 45 years.
• Indistinct sex.
• Women should ensure the continued use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
• Present blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.

Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.

• Blood chemistry of three elements (QS): Glucose, urea and creatinine.

• Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.

  • Present visual ability 20/30 or better in both eyes.
  • Present vital signs within normal parameters.
  • Present intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

• Be a user of topical ophthalmic products of any kind.
• Be a user of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
• In case of being a woman, being pregnant or breastfeeding.
• Have participated in clinical research studies 90 days prior to inclusion in the present study.
• Have previously participated in this same study.
• Be a user of contact lenses and can not suspend their use during the study.
• That they can not follow the lifestyle considerations described in section 6.2.2
• Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion in the present study.
• Having a history of any chronic-degenerative disease.
• Present inflammatory or infectious disease, active at the time of admission to the study.
• Present injuries or unresolved traumas at the time of entering the study.
• Having the antecedent of any type of eye surgery.
• Having undergone surgical procedures, not ophthalmological, in the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO-179; Dosage: 1 drop every 24 hours, at night, in both eyes.	Drug: PRO 179; Generic name: Travoprost; Distinctive denomination: Bristrio® (PRO-179); Active principles: Travoprost 0.004%.; Pharmaceutical form: Ophthalmic solution; Presentation: multi-dose dropper bottle, 2.5 milliliters.; Prepared by: Sophia Laboratories, S.A. of C.V.; Description of the solution: transparent solution, free of visible particles.; Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.; Other Names: PRO-179; Bristrio®; Travoprost 0.004% ophthalmic solution
Active Comparator: Travatan®; Dosage: 1 drop every 24 hours, at night, in both eyes.	Drug: Travatan 0.004 % Ophthalmic Solution; Generic name: Travoprost; Distinctive denomination: Travatan®; Active ingredients: Travoprost 0.004%; Pharmaceutical form: Ophthalmic solution.; Presentation: multi-dose dropper bottle, 2.5 milliliters.; Prepared by: Alcon Laboratories Inc.; Description of the solution: transparent solution, free of visible particles.; Consult information to prescribe.; Other Names: Travoprost 0.004% ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.	during the 14 days of evaluation, including the safety call (day 14).
Eye Comfort Index	It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).	will be evaluated at the end of the treatment, at the final visit (day 11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyes With Epithelial Defects by Grade	The epithelial defects will be evaluated by means of two stains, lissamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.	will be evaluated at the end of the treatment, at the final visit (day 11)
Visual Ability	The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and the worst vision is 20/200, higher values represent a worst vision. The result of the Snellen chart has equivalents in an international logarithmic system called Logmar (logarithm of the minimum angle of resolution) for better understanding. Snellen Scale: 20/200, 20/100, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10. Snellen / LogMAR equivalences: 20/200= 1.0, 20/100=0.7, 20/50=0.4, 20/40=0.3, 20/30=0.2, 20/25=0.1, 20/20=0.0, 20/15=0.13, 20/12=0.2, 20/10=-0.3, etc.	will be evaluated at the end of the treatment, at the final visit (day 11)
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade	Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.	will be evaluated at the end of the treatment, at the final visit (day 11)
Number of Eyes of Chemosis	The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.	will be evaluated at the end of the treatment, at the final visit (day 11)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Intraocular Pressure	the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg	will be evaluated at the end of the treatment, at the final visit (day 11)

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.

Publications and helpful links

General Publications

• Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: glaucoma; Prostaglandin Analogues; Travoprost; ophthalmic solution; Antiglaucoma drugs
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: SOPH179-0818/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No